Safety and Efficacy of Evolocumab in Combination With Statin Therapy in Adults With Diabetes and Hyperlipidemia or Mixed Dyslipidemia (BERSON)

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Amgen

Status and phase

Completed
Phase 3

Conditions

Diabetes, Hyperlipidemia, Mixed Dyslipidemia

Treatments

Biological: Evolocumab
Drug: Atorvastatin
Other: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT02662569
20120119
2013-000723-14 (EudraCT Number)

Details and patient eligibility

About

The primary objective of this study was to evaluate the effect of 12 weeks of subcutaneous evolocumab (AMG 145) in combination with statin therapy (atorvastatin) on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in diabetic adults with hyperlipidemia or mixed dyslipidemia.

Enrollment

986 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Males and females with type 2 diabetes (receiving pharmacologic treatment for at least 6 months or longer) with stable diabetes therapy
  • Lipid-lowering therapy must be unchanged for at least 4 weeks or more
  • Subjects receiving statin therapy at screening must have a fasting LDL-C of greater than or equal to 100 mg/dL
  • Subjects not receiving statin therapy at screening must have a fasting LDL-C of greater than or equal to 130 mg/dL

Exclusion criteria

  • New York Heart Association (NYHA) class III or IV heart failure
  • Uncontrolled cardiac arrhythmia
  • Uncontrolled hypertension
  • Type 1 diabetes or poorly controlled type 2 diabetes
  • Uncontrolled hypothyroidism or hyperthyroidism.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

986 participants in 4 patient groups

Atorvastatin (Q2W)
Active Comparator group
Description:
Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and 20 mg atorvastatin orally once a day for up to 12 weeks.
Treatment:
Other: Placebo
Drug: Atorvastatin
Atorvastatin (QM)
Active Comparator group
Description:
Participants received placebo subcutaneous injection once a month (QM) and 20 mg atorvastatin orally once a day for up to 12 weeks.
Treatment:
Other: Placebo
Drug: Atorvastatin
Evolocumab Q2W + Atorvastatin
Experimental group
Description:
Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and 20 mg atorvastatin orally once a day for up to 12 weeks.
Treatment:
Drug: Atorvastatin
Biological: Evolocumab
Evolocumab QM + Atorvastatin
Experimental group
Description:
Participants received 420 mg evolocumab by subcutaneous injection once a month and 20 mg atorvastatin orally once a day for up to 12 weeks.
Treatment:
Drug: Atorvastatin
Biological: Evolocumab

Trial documents
2

Trial contacts and locations

110

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Data sourced from clinicaltrials.gov

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